Cornaris Intravascular Imaging System

GUDID 06971141530494

Shenzhen Vivolight Medical Device & Technology Co., Ltd.

Coronary optical coherence tomography system

• Primary Device ID: 06971141530494
• NIH Device Record Key: 5fb5a4c8-e8e9-4b92-9173-6fb608d373b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cornaris Intravascular Imaging System
• Version Model Number: P80-E
• Company DUNS: 543028475
• Company Name: Shenzhen Vivolight Medical Device & Technology Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06971141530494 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242098

FDA Product Code

• NQQ: System, Imaging, Optical Coherence Tomography (Oct)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-10-06
• Device Publish Date: 2025-09-28

On-Brand Devices [Cornaris Intravascular Imaging System]

• 06971141530500: Mobile-E
• 06971141530494: P80-E